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Table 1 Procedures in the Identification study

From: Study protocol: DexaDays-2, hydrocortisone for treatment of dexamethasone-induced neurobehavioral side effects in pediatric leukemia patients: a double-blind placebo controlled randomized intervention study with cross-over design

Day

1

2

3

4

5

6

7

8

Timepoint Procedure

T1

    

T2

 

T2a

Standard medication

 Dexamethasone

X

X

X

X

X

   

 Vincristine

X

       

 Methotrexate

X

      

X

Questionnaires

 SDQ

X

    

X

  

 SDSC

X

    

X

  

 PSI

X

    

X

  

 DT

X

       

 DT (short)

     

X

  

 Support

X

       

 Support (short)

     

X

  

 Eating thermometer

X

    

X

  

Blood sample

 Genetics

X

       

 Dexa peak level

X

       

 Dexa trough level

     

X

 

X

Somatic parameters

        

 Weight

X

    

X

 

X

 Height

X

    

X

 

X

 Blood pressure

X

    

X

 

X

Done at (h = home / H = hospital)

H

h

h

h

h

H

h

H

  1. The Identification study is the cohort from which eligible candidates for the Randomized Controlled Trial are selected. T1 = start dexamethasone. T2 = after 5 days of dexamethasone. T2a = 2 days after stop dexamethasone. See Fig. 1 for a schematic overview
  2. SDQ  Strengths and difficulties questionnaire, SDSC Sleep disturbance scale for children, PSI  Parenting stress index, DT  Distress thermometer, PedsQL Pediatric quality of life questionnaire